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Patient-specific devices and population-level evidence: evaluating therapeutic interventions with inherent variation

journal contribution
posted on 08.01.2021, 04:29 by Mary WalkerMary Walker
© 2017, Springer Science+Business Media B.V. Designing and manufacturing medical devices for specific patients is becoming increasingly feasible with developments in 3D printing and 3D imaging software. This raises the question of how patient-specific devices can be evaluated, since our ‘gold standard’ method for evaluation, the randomised controlled trial (RCT), requires that an intervention is standardised across a number of individuals in an experimental group. I distinguish several senses of patient-specific device, and focus the discussion on understanding the problem of variations between instances of an intervention for RCT evaluation. I argue that, despite initial appearances, it is theoretically possible to use RCTs to evaluate some patient-specific medical devices. However, the argument reveals significant difficulties for ensuring the validity of such trials, with implications for how we should think about methods of evidence gathering and regulatory approaches for these technologies.

Funding

My thanks to Robert Sparrow, Wendy Rogers, David Wotton, Tajanka Mladenovska, and the anonymous referees for this journal, for their comments on previous drafts. The funding was provided by Australian Research Council (Grant No. CE140100012)

History

Publication Date

01/01/2018

Journal

Medicine, Health Care and Philosophy

Volume

21

Issue

3

Pagination

11p. (p. 335-345)

Publisher

Springer Nature

ISSN

1386-7423

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